Technical Project Manager
vor 1 Woche
Technical Project Manager
Do you have a solid experience in qualification and validation within the biopharmaceutical industry? And now you want to step into a technical leadership role?
Here is an exciting opportunity for you to expand your knowledge.
Your responsibilities
Project Scope and Strategy Development:
- Define the technical requirements and success criteria for the project, ensuring alignment with GMP standards, operational goals, and compliance expectations.
- Collaborate with stakeholders to integrate operational improvements into the overall project plan.
- Develop a comprehensive roadmap for the project lifecycle, from conceptual design through performance qualification (PQ).
Technical Leadership:
- Act as the primary technical point of contact for the project, ensuring all mechanical adaptations and operational improvements meet required specifications.
- Coordinate with EPCM teams to ensure alignment of engineering deliverables with technical and operational requirements.
- Provide guidance and support to production staff implementing operational improvements.
Quality and Compliance Oversight:
- Ensure that all project activities comply with GMP regulations and internal quality standards.
- Collaborate with QA teams to manage GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs).
Cross-Functional Coordination:
- Liaise with operations, maintenance, engineering, and quality teams to ensure seamless integration of mechanical adaptations into production.
- Facilitate communication and alignment between the production staff and the EPCM to address any technical challenges or deviations.
Project Execution and Monitoring:
- Monitor the progress of technical and operational activities to ensure milestones are met on time and within budget.
- Conduct risk assessments and develop mitigation plans for potential project roadblocks.
- Provide regular updates and technical reports to project stakeholders.
Testing and Qualification:
- Lead the planning and execution of equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
- Oversee and coordinate with validation teams to ensure the effectiveness and reliability of the implemented changes.
Your qualifications
- Degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or a related field.
- 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on technical project management or operational excellence.
- Proven experience working on GMP-compliant projects, including change management and qualification activities.
- Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes in a GMP environment.
- Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
- Proficiency in project management tools and methodologies.
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